Comparative evaluation of Subcision followed by Microneedling versus Subcision followed by Injectable Platelet-Rich Fibrin in the management of Atrophic Acne Scars
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To assess scar improvement using Echelle d’Evaluation Clinique des Cicatrices d’acne (ECCA) score
研究概览
简要总结
Research question-
Is Subcision followed by microneedling more effective than Subcision followed by injectable platelet-rich fibrin (iPRF) for treatment of atrophic acne scars?
Study Design- This will be a two-year prospective interventional study conducted in the Department of Dermatology, Venereology and Leprosy of AVBRH, Sawangi (Meghe).
Study Setting- Patients having atrophic acne scars coming to Department of Dermatology, Venerology and Leprosy, Acharya Vinoba Bhave Rural Hospital, Sawangi (Meghe), Wardha.
Study Population- Patients having atrophic acne scarring, including both genders and >18 years of age, coming to the Dermatology, Venereology and Leprosy (DVL) department at Acharya Vinoba Bhave Rural Hospital, Sawangi (Meghe), Wardha will be included in the study.
Sample size- 40
Methodology- A total of 40 patients attending the outpatient department of Dermatology, Venerology and Leprosy, AVBRHfor the management of acne scars will be enrolled for this study. All enrolled patients will be informed about the procedure, including potential side effects, and written informed consent will be obtained prior to participation. Detailed history and thorough dermatological, physical and systemic examination will be conducted. They will be graded according to the ECCA scoring. Patients will then be randomised into two groups based on computer-generated randomisation. Group A will be treated with Subcision followed by Microneedling and Group B will be treated with Subcision followed by Injectable Platelet rich fibrin. Subcision will be done in the first session followed by either Microneedling or Injectable Platelet-Rich Fibrin (iPRF) in the subsequent session. Clinical photographs of front, left and right profile of face will be taken and ECCA scoring will be done with the patient’s informed consent at every visit
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients above 18 years of age.
- •Patients who have given written consent before treatment is commenced.
- •Patients with atrophic acne scars (rolling, boxcar, or ice pick).
- •Patients who are willing to comply with treatment protocols and follow-up visits.
排除标准
- •Patients with history of hypertrophic scars and keloid.
- •Patients with active acne lesions.
- •Patients with contraindications to Subcision, Microneedling, or iPRF (e.g., bleeding disorders, coagulation disorders, any active skin infections like herpes, etc.).
- •Patients with unrealistic expectations.
- •Seropositivity for HIV, Hepatitis B and Hepatitis C.
结局指标
主要结局
To assess scar improvement using Echelle d’Evaluation Clinique des Cicatrices d’acne (ECCA) score
时间窗: At the end of study (After 2 years)
次要结局
未报告次要终点
研究者
Heeral Vadera
Jawaharlal Nehru Medical College, Sawangi, Meghe, Wardha